NDC 0187-0731

WELLBUTRIN XL

Bupropion Hydrochloride

WELLBUTRIN XL is a Oral Tablet, Extended Release in the Human Prescription Drug category. It is labeled and distributed by Bausch Health Us Llc. The primary component is Bupropion Hydrochloride.

• Product ID: 0187-0731_195ac110-0d0e-4f1c-aaae-7ff5bb41a0cf
• NDC: 0187-0731
• Product Type: Human Prescription Drug
• Proprietary Name: WELLBUTRIN XL
• Generic Name: Bupropion Hydrochloride
• Dosage Form: Tablet, Extended Release
• Route of Administration: ORAL
• Marketing Start Date: 2003-08-29
• Marketing Category: NDA / NDA
• Application Number: NDA021515
• Labeler Name: Bausch Health US LLC
• Substance Name: BUPROPION HYDROCHLORIDE
• Active Ingredient Strength: 300 mg/1
• Pharm Classes: Aminoketone [EPC],Dopamine Uptake Inhibitors [MoA],Increased Dopamine Activity [PE],Increased Norepinephrine Activity [PE],Norepinephrine Uptake Inhibitors [MoA]
• NDC Exclude Flag: N
• Listing Certified Through: 2021-12-31

Packaging

NDC 0187-0731-07

7 TABLET, EXTENDED RELEASE in 1 BOTTLE (0187-0731-07)

• Marketing Start Date: 2003-08-29
• NDC Exclude Flag: N
• Sample Package?: N

NDC SPL Data Element Entries

NDC 0187-0731-30 [00187073130]

WELLBUTRIN XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021515
• Product Type: HUMAN PRESCRIPTION DRUG
• Billing Unit: EA
• Marketing Start Date: 2003-08-29

NDC 0187-0731-07 [00187073107]

WELLBUTRIN XL TABLET, EXTENDED RELEASE

• Marketing Category: NDA
• Application Number: NDA021515
• Product Type: HUMAN PRESCRIPTION DRUG
• Marketing Start Date: 2003-08-29

Drug Details

Active Ingredients

Ingredient	Strength
BUPROPION HYDROCHLORIDE	300 mg/1

OpenFDA Data

• SPL SET ID: a435da9d-f6e8-4ddc-897d-8cd2bf777b21
• Manufacturer:
  • Valeant Pharmaceuticals North America LLC
• UNII:
  • ZG7E5POY8O
• RxNorm Concept Unique ID - RxCUI:
  • 993557
  • 993541
  • 993564
  • 993545

Pharmacological Class

• Aminoketone [EPC]
• Dopamine Uptake Inhibitors [MoA]
• Increased Dopamine Activity [PE]
• Increased Norepinephrine Activity [PE]
• Norepinephrine Uptake Inhibitors [MoA]

NDC Crossover Matching brand name "WELLBUTRIN XL" or generic name "Bupropion Hydrochloride"

NDC	Brand Name	Generic Name
21695-138	WELLBUTRIN XL	WELLBUTRIN XL
21695-137	WELLBUTRIN XL	WELLBUTRIN XL
0187-0731	WELLBUTRIN XL	WELLBUTRIN XL
0187-0730	WELLBUTRIN XL	WELLBUTRIN XL
0115-5445	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE
0115-6811	Bupropion Hydrochloride	BUPROPION HYDROCHLORIDE
0185-0410	Bupropion Hydrochloride	Bupropion Hydrochloride
0185-0415	Bupropion Hydrochloride	Bupropion Hydrochloride
0185-1111	Bupropion Hydrochloride	Bupropion Hydrochloride
0173-0135	WELLBUTRIN	bupropion hydrochloride
0173-0722	WELLBUTRIN	bupropion hydrochloride
0173-0947	WELLBUTRIN	bupropion hydrochloride
0173-0556	ZYBAN	bupropion hydrochloride